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Clinical Trial Summary

A prospective controlled, randomized study to examine the effects of behavioral and wellness-based interventions on seizure frequency for adult patients with medication resistant epilepsy who are still experiencing 1 or more seizures per month.


Clinical Trial Description

In this prospective controlled, randomized study, investigators aim to assess the impact of integrative behavioral and wellness-based interventions on seizure frequency (primary outcome measure), stress, cognitive function, and quality of life (secondary outcome measures) in patients with difficult to treat epilepsy. The study team will accomplish these objectives through three active interventions that include: cognitive behavioral therapy (CBT), yoga therapy, and music therapy. This study will have two control groups who will continue with their standard of care as guided by their epilepsy provider. Investigators will measure the effects of our interventions using seizure diaries, cognitive assessments, and health and quality of life questionnaires. In this study, the study team will collect, process, store, and analyze human biospecimens of enrolled participants for research purposes to assess the potential biologic impact of our interventions. Collection, processing, storage, and data management of the biospecimens to be used for this study, and future studies, will be completed through Lerner Research Institute. The CBT arm is currently closed to enrollment as of 8/14/2023. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05283200
Study type Interventional
Source The Cleveland Clinic
Contact Arden Bischof, MS
Phone 216-444-3652
Email bischoa2@ccf.org
Status Recruiting
Phase N/A
Start date February 11, 2022
Completion date June 2026

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